- Approval Id
- e96bc11ae741b4d2
- Drug Name
- Asmanex Twisthaler 100mcg/inhalation
- Product Name
- Asmanex Twisthaler 100mcg/inhalation
- Approval Number
- SIN13630P
- Approval Date
- 2009-04-15
- Registrant
- ORGANON SINGAPORE PTE. LTD.
- Licence Holder
- ORGANON SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- POWDER, METERED
- Dosage
- **DOSAGE AND ADMINISTRATION**
ASMANEX\* TWISTHALER\* should be administered by oral inhalation only. After each dose, patients should be advised to rinse their mouth with water and spit out the contents without swallowing.
ASMANEX\* TWISTHALER\* is intended for use in adults, adolescents and pediatrics 4 years of age and older.
Mild to moderate asthma (patients ≥ 12 years of age):
The recommended starting dose of ASMANEX\* TWISTHALER\* therapy for patients with mild to moderate asthma is 400 micrograms once daily. Data suggests that better asthma control is achieved if once daily dosing is administered in the evening. Some patients, such as those previously on high doses of inhaled corticosteroids, may be more adequately controlled on a dose of 400 micrograms daily given in 2 divided doses (200 micrograms BID).
A dose reduction to 200 micrograms once daily given in the evening may be an effective maintenance dose for some patients.
The dose should be individualised and titrated to the lowest dose at which effective control of asthma is maintained.
Severe asthma (patients ≥ 12 years of age):
For patients with severe asthma who may require oral corticosteroids, the recommended starting dose of ASMANEX\* TWISTHALER\* is 400 micrograms twice daily, which is the maximum recommended dose. Once reduction of oral steroid dose is complete (see below) or symptoms are controlled, titrate ASMANEX\* TWISTHALER\* to the lowest effective dose.
Inhaled mometasone furoate demonstrated improved lung function within 24 hours after the first dose. In some patients, however, maximum benefit may not be achieved before 1 to 2 weeks or longer.
Pediatric asthma patients (4 to 11 years of age):
The recommended dose is 100 micrograms once daily given in the evening.
The patient should be made aware of the prophylactic nature of this product and be instructed to use it regularly to maintain therapeutic benefit, even when no symptoms are present.
The patient needs to be instructed how to use the inhaler correctly.
Prior to removing the cap, be sure the dose counter and the pointer on the cap are aligned and the inhaler is held upright with the coloured\* base at the bottom. The inhaler can be opened by removing the white cap while holding the coloured base, gripping the base and twisting the cap counterclockwise. Upon removal of the cap, the counter will register the number down by one count. Instruct the patient to place the inhaler in the mouth, closing the lips around the mouthpiece (do not cover the ventilation holes), and to breathe in rapidly and deeply. Then, the inhaler is removed from the mouth, and the breath is held for about 10 seconds, or as long as comfortable. The patient is not to breathe out through the inhaler. The inhaler must be kept clean and dry at all times. The outside of the mouthpiece can be cleaned with a dry cloth or tissue. The inhaler must not be cleaned with water. To close, replace the cap immediately after each inhalation while holding the unit upright, loading for next dose by rotating the cap clockwise while gently pressing down until a click sound is heard and the cap is fully closed. The arrow on the cap will be fully aligned with the counter window. Rinsing the mouth after inhalation is advised. This helps to reduce the risk of candidiasis.
\\* Grey for 100 micrograms, pink for 200 micrograms and maroon for 400 micrograms
The digital dose counter display will indicate the number of doses remaining. After dose 01, the counter will read 00 and the cap will lock, at which time the unit must be discarded.
Initially, in patients with severe asthma, ASMANEX\* TWISTHALER\* inhaler is for use concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is initiated by reducing the daily or alternate daily dose. The next reduction is made after an interval of one to two weeks, depending on the response of the patient. Generally, these decrements are not to exceed 2.5 mg of prednisone daily or its equivalent. A slow rate of withdrawal is strongly recommended. During withdrawal of oral corticosteroids, patients must be carefully monitored for signs of unstable asthma, including objective measures of airway function, and for adrenal insufficiency (see PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). During dose reduction, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients are to be encouraged to continue with ASMANEX\* TWISTHALER\* treatment, but must be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, increase the systemic corticosteroid doses temporarily and thereafter continue withdrawal more slowly. During periods of stress or severe asthma attack, these patients may require supplementary treatment with systemic corticosteroids.
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- **INDICATIONS AND USAGE**
Adults and adolescents 12 years and older ASMANEX\* TWISTHALER\* inhaler is indicated as prophylactic therapy in the management of all severities of asthmatic patients, including those who have been dependent upon either inhaled or systemically administered corticosteroids, and non-corticosteroid-dependent patients inadequately controlled on other drug regimens.
Pediatric patients ages 4 through 11 years: ASMANEX\* TWISTHALER\* is also indicated for the maintenance treatment of asthma as prophylactic therapy.
- Contraindications
- **CONTRAINDICATIONS**
Patients with known hypersensitivity to mometasone furoate or to milk proteins, which are contained in the excipient lactose.
- Atc Code
- R03BA07
- Atc Item Name
- mometasone
- Pharma Manufacturer Name
- ORGANON SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/organon-singapore-pte-ltd
